FDA-Device2018-03-07Class II
Stage-1¿ RDS Indexed Abutment for RDS Stage-1¿ Single Stage Implants Keystone s implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations and terminal or intermediate abutment support for fixed bridgework.
Keystone Dental Inc
Hazard
The recalled units are mislabeled with an incorrect expiration date. The expiration date printed on the label is 2202-06. The correct expiration date should be 2022-06.
Sold states
Nationally.
Affected count
20
Manufactured in
154 Middlesex Tpke, N/A, Burlington, MA, United States
Products
Stage-1¿ RDS Indexed Abutment for RDS Stage-1¿ Single Stage Implants Keystone s implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations and terminal or intermediate abutment support for fixed bridgework.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0727-2018Don't want to check this manually?
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